Novo Nordisk scores major legal win that bars many compounded versions of Wegovy, Ozempic
Flags with the logos of Danish drugmaker Novo Nordisk, maker of the blockbuster diabetes and weight-loss treatments Ozempic and Wegovy are pictures while the company presents the annual report at Novo Nordisk in Bagsvaerd, Denmark, on February 5, 2025.
Mads Claus Rasmussen | Afp | Getty Images
Novo Nordisk scored a huge legal victory that largely restricts compounding pharmacies from marketing or selling cheaper, unapproved versions of the drugmaker's blockbuster weight loss drug Wegovy and diabetes treatment Ozempic.
A federal judge in Texas late Thursday rejected a bid by compounding pharmacies to keep making copies of Ozempic and Wegovy while a legal challenge over the shortage of those drugs unfolds. That came in response to a February lawsuit from a compounding trade group against the Food and Drug Administration's determination that the active ingredient in those drugs, semaglutide, is no longer in shortage in the U.S.
Patients flocked to the cheaper copycats when Ozempic and Wegovy were in short supply over the last two years due to skyrocketing demand, or if they didn't have insurance coverage for the costly treatments.
During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. Many telehealth companies, such as Hims & Hers , also offered those copycats. But drugmakers and some health experts have pushed back against the practice because the FDA does not approve compounded drugs, which are essentially custom-made copies prescribed by a doctor to meet a specific patient's needs.
'We are pleased the court has rejected the compounders' attempts to undermine FDA's data-based decision that the shortage' of semaglutide is resolved, said Steve Benz, Novo Nordisk's corporate vice president, legal and U.S. general counsel, in a statement.
'Patient safety remains a top priority for Novo Nordisk and the extensive nationwide legal actions we have taken to protect Americans from the health risks posed by illegitimate 'semaglutide' drugs are working,' he said, referring to the company's more than 100 lawsuits against compounding pharmacies and other entities across 32 states.
On Thursday, U.S. District Judge Mark Pittman specifically denied the Outsourcing Facilities Association's bid for a preliminary injunction that would have prevented the FDA from taking action against its members for making copies of semaglutide.
That decision upholds the FDA's previous determination that the semaglutide shortage in the U.S. is over and means the FDA can now immediately go after so-called 503A pharmacies that are making compounded versions of semaglutide according to individual prescriptions for a specific patient.
Those pharmacies are largely regulated by states rather than the FDA.
The decision also means the FDA can start targeting federally regulated 503B pharmacies, which manufacture compounded drugs in bulk with or without prescriptions, after May 22. The agency's actions can include product seizures and warning letters to pharmacies.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
38 minutes ago
- Yahoo
"Maintaining Strong Bones Has Less To Do With Drinking Tons Of Milk": Experts Are Sharing What To Foods May Negatively Impact Your Bone Density
My grandmother has osteoporosis, along with 10 million other Americans diagnosed with the disease and 43 million others with low bone mass. Not wanting to follow in her hobbled footsteps, the rest of the women in the family are taking precautions, including consuming the recommended amount of calcium (more isn't necessarily better), adding weight-bearing exercises to our exercise regimens and attending regular doctor checkups. But according to orthopedic specialists, protecting and maintaining strong bones has less to do with drinking tons of milk (those Got Milk campaigns certainly had their intended effect) and more to do with avoiding foods and beverages that can impact our bone density. Folks concerned about osteoporosis often add calcium and vitamin D to their diets, but these supplements could hurt your bone health rather than help if not taken as needed. Dr. Liz Matzkin, associate professor at Brigham and Women's Hospital in the Department of Orthopedic Surgery in Boston, explained: 'Although calcium and Vitamin D is important to maintain bone health, exceeding the recommended doses per day can backfire and be harmful rather than beneficial. Calcium and vitamin D requirements are age dependent, so make sure you are aware of the optimal dose for you.' She advised that, for ages 50 and over, the recommendations are 1,000 milligrams per day of calcium and 800 to 1000 international units per day of vitamin D. Below, orthopedic surgeons and specialists share the foods they avoid to help lessen their risk of osteoporosis. Alcohol Related: This Picky Eater Showdown Will Be Tough For People Without Refined Palates We don't blame you if you're totally confused about whether alcohol is a healthy or unhealthy addition to your diet. Whether you've heard it's beneficial for heart health or are concerned about its effect on the liver, Matzkin cautions that sipping a few glasses of pinot or chugging lagers can negatively affect bone health. 'An increased consumption of alcohol can alter the body's ability to absorb important nutrients that are actually beneficial to bone health, such as calcium, vitamin D and magnesium,' she explained. While calcium and vitamin D often get the spotlight in this area, our sex hormones, like testosterone in men and estrogen in women, are also critical for ensuring strong bones. Angelina Waller, a physician assistant at Advanced Orthopedics in Denver, explained that alcohol 'slows the bone remodeling cycle and disrupts hormone levels.' If you do like to imbibe, Matzkin recommends no more than one alcoholic beverage per day (which is the maximum amount women should be drinking anyway, according to the Centers for Disease Control and Prevention). Older folks and those who are at risk of bone breakage should be especially cautious. 'Lastly, if you consume too much alcohol, there is a higher risk of falling and injuring or fracturing a bone,' Matzkin said. A 2018 study found a link between alcohol consumption and hip fractures. Caffeine Related: If Your Fruit And Vegetable Knowledge Is Actually Good, Prove It By Getting 22/27 Of These Questions Right While America runs on coffee, it doesn't fuel our bones. And not just coffee. Add energy drinks, soda, tea and supplements or any product with caffeine to the hit list. Just like alcohol, the idea isn't abstention but moderation. 'Caffeine has been shown to increase calcium loss and decrease calcium absorption, both of which negatively influence bone health,' Matzkin said. 'Consider decaffeinated coffee or tea options if you just need something to warm you up or, even better, a tall glass of water.' The Food and Drug Administration recommends no more than 400 milligrams of caffeine a day (about 4-5 cups of coffee), which is a good guideline to use for bone health too. The bone builder vitamin D is also affected by caffeine, which can interfere with absorption. 'Caffeine causes decreased calcium absorption and increased calcium loss in the urine,' Waller said. Soda, particularly cola, is also a culprit of bad bone health. A 2006 comparative study found that drinking cola (including diet versions!) was associated with significantly lower bone mineral density in women. The level of consumption is related to the problem: The more cola the women drank, the more significant its impact. 'Soda contains sugars and can also contain phosphoric acid and caffeine,' Matzkin said. 'All of which fail to have any health benefits and, if consumed in large quantities, will result in negative health consequences.' Wheat Bran It may come as a surprise that heart-healthy wheat bran can have a negative effect on bone health. 'Wheat bran has high levels of phytates, which can prevent calcium absorption,' Matzkin explained. Many people eat wheat bran because it's high in dietary fiber, which is essential for keeping you regular, decreasing heart disease and even preventing colon cancer, all important considerations for many Americans. Thankfully, if you're a consumer of oat bran (which is different from wheat bran), it doesn't have the same deleterious effects on bones as wheat bran, according to Matzkin, as it doesn't contain high levels of phytates. Phytates are a type of anti-nutrient naturally found in plants. Many of your favorite veggies and legumes (from kale and cabbage to beans and peanuts) contain compounds that reduce the absorption of other nutrients. Pseudoscience makes a big deal out of avoiding these compounds, but for the most part, there's no reason to avoid these otherwise-healthy foods. Beans, spinach and beets also contain anti-nutrients that can decrease calcium absorption, but soaking (in the case of dried beans) or cooking (for raw spinach and beets) lessens their impact, according to Waller. 'Beans and wheat bran contain phytates, and spinach and beets contain oxalates that decrease calcium absorption as they bind to the calcium,' she said. If you want to reduce the phytates in wheat bran, you can try soaking, sprouting or fermenting it. Since it has tons of other benefits, there's no need to completely remove it from your diet, just moderate your intake. 'As with almost all foods, moderation is key,' Matzkin said. 'No need to completely eliminate wheat bran from the diet, but understanding that it can affect [calcium] absorption should prompt supplementation with other [calcium]-rich foods.' Salt Whether your tastes run salty or sweet or salty-sweet, the white stuff is typically associated with high blood pressure rather than bone loss. But it really should be a consideration for bone health, especially for older and at-risk groups. 'Be aware of salt that can be hidden in meats, snacks and processed foods such as cold cuts,' Matzkin said. 'Consuming excessive amounts of salt (more than 2,300 milligrams per day) can lead to calcium loss from your bones.' According to a 2018 study by the Journal of the American College of Nutrition, increased sodium consumption significantly increased the risk of osteoporosis. To put that in perspective, 2,300 milligrams per day is equal to 1 teaspoon of table salt, according to the FDA. On average, Americans are eating 1.5 times that amount. This post originally appeared on HuffPost. Also in Food: I'm Not Calling You Uncultured, But If You Can't Pass This International Food Also in Food: People Are Sharing The "Unneccessary" Cooking Rules They Stopped Following Ages Ago Also in Food: If You Can't Name At Least 10 Of These Fruits, You've Got The Taste Buds Of A Toddler
Miami Herald
2 hours ago
- Miami Herald
Dave Ramsey sends major message to Americans on IRAs, Roth IRAs
Americans preparing for retirement encounter various challenges, primarily centered on maintaining financial security and sustaining the lifestyle they envision after leaving the workforce. Key concerns involve estimating potential Social Security payments and evaluating how much they will be able to depend on their accumulated retirement funds. Dave Ramsey, bestselling personal finance author and radio host, offers important words for Americans on traditional IRAs, Roth IRAs and some key advice on ways to achieve a financially comfortable retirement. Don't miss the move: Subscribe to TheStreet's free daily newsletter Making sure retirement funds can adequately cover future expenses is a top priority for many Americans. With rising life expectancies and the uncertainty of financial markets, retirees must strategize how to extend their savings throughout their retirement years. To build financial security, individuals wisely invest in 401(k)s, IRAs, and similar accounts while factoring in tax considerations. Another significant concern is health care costs, which tend to increase as medical needs grow with age. Although Medicare helps alleviate some expenses, it does not cover everything, requiring retirees to account for out-of-pocket costs such as medications, long-term care, and some additional medical services. Related: Dave Ramsey warns Americans on Social Security The impact of rising inflation is a significant concern, as it reduces the purchasing power of fixed retirement incomes. Many retirees worry that inflation could hinder their ability to maintain their preferred lifestyle, especially those who depend heavily on Social Security benefits. While Social Security remains a crucial source of retirement income, relying on it entirely brings uncertainty. Questions surrounding its long-term viability, cost-of-living adjustments, and possible benefit reductions due to solvency concerns add to the financial stress many retirees face. Recognizing these challenges, Ramsey issues a caution regarding traditional IRAs and Roth IRAs, offering Americans guidance on setting financial priorities and navigating the complexities of retirement planning. Ramsey explains that both Roth IRAs and traditional IRAs are valuable tools for retirement savings, but the key distinction lies in how they are taxed. A Roth IRA is funded with after-tax dollars, allowing investments to grow tax-free. When retirement arrives, withdrawals from the Roth IRA remain tax-free, providing financial flexibility. In contrast, a traditional IRA is funded with pretax money, offering an immediate tax advantage. However, when funds are withdrawn during retirement, both the contributions and their accumulated growth are subject to taxation. "While a Roth IRA doesn't offer any current-year tax benefits like a traditional IRA, it gives you something even better: tax-free growth and tax-free withdrawals once you retire," Ramsey wrote. "Now, that's a sweet deal!" More on retirement: Dave Ramsey sounds alarm for Americans on Social SecurityScott Galloway warns Americans on 401(k), US economy threatShark Tank's Kevin O'Leary has message on Social Security, 401(k)s Another significant difference between these accounts is the income limits. A traditional IRA has no income restrictions, meaning individuals can contribute regardless of how much they earn annually. A Roth IRA, on the other hand, has specific eligibility requirements. In 2025, those filing as single or head of household can contribute the full amount if their gross income is below $150,000. For married couples filing jointly, the threshold is $246,000. Related: Dave Ramsey sends strong message to Americans on 401(k)s Once a person turns 59-and-a-half and has held their Roth IRA for at least five years, they are free to withdraw both contributions and earnings without facing taxes or penalties - an excellent advantage for retirees. However, if one's Roth IRA has been open for less than five years, any earnings they take out will be subject to taxes. In 2025, the Roth IRA contribution limit remains $7,000 for those under 50, translating to a monthly contribution of $583.33 when divided over 12 months. Individuals aged 50 and older can contribute up to $8,000, which allows for monthly contributions of $666.67. These limits require savers to plan smartly, ensuring steady growth in their retirement accounts while optimizing tax advantages, Ramsey explains. By making consistent contributions, individuals can build financial security for their future while taking advantage of tax-free growth. Related: Shark Tank's Kevin O'Leary makes bold prediction on U.S. economy The Arena Media Brands, LLC THESTREET is a registered trademark of TheStreet, Inc.
Hamilton Spectator
3 hours ago
- Hamilton Spectator
U.S. ambassador says Canadians facing device searches, detainment ‘not a pattern'
OTTAWA - The American ambassador to Canada is pushing back on Ottawa's travel advice, saying his country doesn't search phones at the border and arguing some Americans travelling here are having a tough time. 'We welcome Canadians to come in and invest, to spend their hard-earned Canadian dollars at U.S. businesses,' U.S. Ambassador Pete Hoekstra told The Canadian Press in an interview Friday. 'If a Canadian has had a disappointing experience coming into the United States, I'm not denying that it happened, but I'm saying it's an isolated event and it is not a pattern.' In April, Ottawa updated its advice to Canadians travelling to the United States to warn them about the possibility they might be detained if denied entry. 'Expect scrutiny at ports of entry, including of electronic devices,' reads the new guidance. There have been reports of Canadians facing intensified scrutiny at the border, having phones searched and, in some cases, being detained. Hoekstra insisted concerns about device searches are not grounded in reality. 'Coming to the U.S., that's a decision for the Canadians to make. Searching devices and all of that is not a well-founded fear. We don't do that. America is a welcoming place,' he said. He said some Americans have expressed similar concerns about Canada. 'I've heard that from Americans coming into Canada as well, OK? Saying, 'You know, we've not received a warm reception when we've gotten to Canadian customs,'' he said. When asked if these reports from American travellers involve arbitrary phone searches and lengthy detainment, Hoekstra said there are consular cases of Americans complaining to the embassy about the Canada Border Services Agency. 'We've said, 'OK this may have been an isolated event. There may have been a Canadian border person who was having a bad day, and thought they'd take it out on, you know, somebody across the border,'' he said. In a statement, the CBSA said its officers follow a code of conduct and the federal ethics code that both require them to treat everyone equally, and the agency investigates any complaints of mistreatment. 'Employees are expected to conduct themselves in a way that upholds the values of integrity, respect and professionalism at all times,' wrote spokeswoman Karine Martel. 'Treating people with respect, dignity and fairness is fundamental to our border services officers' relationship with the public and a key part of this is serving all travellers in a non-discriminatory way.' Hoekstra said travel to the U.S. is up to individuals. 'If you decide that you're not going to come down or whatever, that's your decision and you're missing an opportunity. There are great things to see in America,' Hoekstra said. He also noted the case of CNN journalist Christiane Amanpour, who recently said she prepared to visit the U.S. last month as if she was 'going to North Korea' — with a 'burner phone' that didn't carry any personal information — only to experience a warm welcome. 'It's like, (let's) get past the rhetoric and let's look at the real experiences that people are having here,' Hoekstra said. Airlines have been cutting flights between Canada and the U.S. due to a slump in demand, and Flight Centre Travel Group Canada reported a nearly 40 per cent drop in flights between the two countries year-over-year in February. A survey in early May conducted by Leger Marketing for the Association for Canadian Studies found 52 per cent of respondents feel that 'it is no longer safe for all Canadians travelling to the United States,' with 29 per cent disagreeing and 19 per cent saying they were unsure. Roughly the same proportion said they personally feel unwelcome in the U.S. LGBTQ+ groups have opted against attending World Pride events in Washington and United Nations events in New York, citing scrutiny at the border as the Trump administration scales back protections for transgender and nonbinary people. This report by The Canadian Press was first published June 7, 2025.
